A critical analysis of surgery for occult tethered cord syndrome.
Marissa M Michael, Andrew L A Garton, Claudia M Kuzan-Fischer...
https://pubmed.ncbi.nlm.nih.gov/34268593Actively Recruiting
Phase Not Applicable
Age: 2Years - 80Years
All Genders
ID05163899
Phase II Pilot Randomized-Controlled Trial of Surgical Release of the Filum Terminale Versus Medical Management in Treating Occult Tethered Cord Syndrome
Led by Weill Medical College of Cornell University · Updated on 2026-05-14
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether surgical release of the filum terminale, a fibrous tissue at the end of the spinal cord, provides better symptom relief than medical management in patients with Occult Tethered Cord Syndrome (OTCS). This phase II pilot randomized-controlled trial aims to assess the preliminary effectiveness and safety of surgery compared to medical treatment for this condition. Participants will be randomly assigned to either undergo surgical untethering of the filum terminale or receive only medical management. Symptom improvement and any adverse events will be monitored and recorded for one year after treatment begins. After at least one year, patients initially receiving medical management may switch to surgery if the principal investigator considers it beneficial. Throughout the study, participants will have their symptoms evaluated using the OCCULT Scale at the start and after one year. Additional assessments include urologic and fecal incontinence scores, medication changes, and intra-operative findings during surgery. Safety and symptom changes will be carefully tracked for one year to understand the treatment effects and risks involved.
CONDITIONS
Brief Title
Investigation of Surgical Sectioning of the Filum Terminale in Treating Occult Tethered Cord Syndrome Patients
Who Can Participate
Age: 2Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female aged 2 to less than 80 years
- Symptoms refractory to medical management for at least 1 year
- Diagnosis of OTCS with a total score of at least 30 on the OCCULT Grading Scale
You will not qualify if you...
- Younger than 2 or older than 80 years
- Radiographically identified tethered cord (low-lying conus at or below L2-3, thickened filum over 2 mm, fat in filum or lipoma, or clear tethering)
- History of Meningocele manqué or Myelomeningocele
- Cutaneous markings of dermal sinus tract
- Prior surgery on the lumbar spine or for spinal dysraphism
- History of central nervous system infection or autoimmune condition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery
Duration - 1 day
Participants randomized to surgery undergo filum terminale release to treat OTCS.
1 surgical procedure and hospital stay
Treatment
Duration - 1 year
Participants receive medical management or recover from surgery while symptoms and adverse events are monitored.
Periodic visits during 1 year of treatment
Follow-up
Duration - At least 1 year after crossover
After 1 year, participants in the medical management arm may cross over to surgery if deemed appropriate and continue to be monitored.
Follow-up visits after crossover surgery
Trial Site Locations
Total: 1 location
1
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
Loading map...
Research Team
C
Cynthia Nguyen
J
Jeffrey Greenfield, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here